Trial | NCT03475407  Report issue

Title

The Effects of Intravitreal Ozurdex Implant in DME
The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.
Study Started
Mar 31
2015
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Mar 23
2018

Drug Ozurdex intravitreal injection

Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline AC paracentesis at 6 wk intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk

Treatment Group Experimental

Ozurdex intravitreal injection

Criteria 

Inclusion Criteria:

The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
Diabetic patients with cystoids macular edema
Minimum central thickness on OCT not less than 300 microns
BCVA 20/30~20/320

Exclusion Criteria:

Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
Patients with history of ocular hypertension or glaucoma
Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
Patients with macular ischemia on FFA
Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
Patients whose posterior lens capsule is not intact.
patients with known hypersensitivity to any components of this product.
patients with vitreous hemorrhage
patients who have systemic treatment effect on study results
patients who enrolled other clinical study
No Results Posted